A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea

Safety and Efficacy of a Topical Otic Formulation in the Treatment of Peri-Operative Tube Otorrhea

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00578773

Enrollment

303

Registered

2007-12-21

Start date

2007-11-30

Completion date

2009-01-31

Last updated

2012-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Otitis Media

Keywords

ear tubes, ear infection, ear drops, ear tube surgery, acute otitis media

Brief summary

The purpose of this study is to determine if an otic formulation is safe and effective in treating peri-operative tube otorrhea.

Interventions

DRUGMoxidex otic solution

4 drops into the infected ear(s) twice daily (morning and evening) for 7 days

DRUGMoxifloxacin otic solution

4 drops into the infected ear(s) twice daily (morning and evening) for 7 days

DEVICETympanostomy tubes

Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

6 Months to 12 Years

Healthy volunteers

Inclusion criteria

* 6 months to 12 years old * Diagnosed with recurrent acute otitis media or chronic otitis media with effusion * Must be first set of ear tubes. * Patient may not have had any other previous otologic-related surgery. * Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube * Patient may not have existing perforation of the eardrum. * Patient must not require another surgical procedure other than myringotomy and tube insertion. * Patient may not be a menarchal female * Diabetic patients are not eligible * Patient may not have any disease or condition that would negatively affect the conduct of the study * Patient may not require any other systemic antimicrobial therapy during the study. * Patient must meet certain medication washouts to be eligible * Analgesic use (other than acetaminophen) is not allowed * Patient may not be pre-disposed to neurosensory hearing loss * Other protocol-defined inclusion criteria may apply

Exclusion criteria

* Age * Other protocol-defined

Design outcomes

Primary

Measure	Time frame
Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary	From baseline

Secondary

Measure	Time frame
Clinical cures at each visit	From baseline
Absence of otorrhea at each visit	From baseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026